Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-02 @ 9:29 AM
Study NCT ID:
NCT06397092
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2024-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthetic Management for TA-BSM in HOCM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2024-04-07', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative information 1', 'timeFrame': 'During surgery, when use isoproterenol to provocate', 'description': 'Heart reat'}, {'measure': 'Perioperative information 2', 'timeFrame': 'During surgery, when use isoproterenol to provocate', 'description': 'Systolic arterial blood pressure'}, {'measure': 'Perioperative information 3', 'timeFrame': 'During surgery, when use isoproterenol to provocate', 'description': 'Diastolic arterial blood pressure'}, {'measure': 'Perioperative information 4', 'timeFrame': 'During surgery, when use isoproterenol to provocate', 'description': 'Mean arterial blood pressure'}, {'measure': 'Perioperative information 5', 'timeFrame': 'Immediately after the surgery', 'description': 'The type of tracheal tube'}, {'measure': 'Perioperative information 6', 'timeFrame': 'Immediately after the surgery', 'description': 'The usage of anaesthetic drugs'}, {'measure': 'Perioperative information 7', 'timeFrame': 'Immediately after the surgery', 'description': 'The usage of cardiovascular drugs'}, {'measure': 'Perioperative information 8', 'timeFrame': 'Immediately after the surgery', 'description': 'Intraoperative infusion volume'}, {'measure': 'Perioperative information 9', 'timeFrame': 'Immediately after the surgery', 'description': 'Blood transfusion volume'}, {'measure': 'Perioperative information 10', 'timeFrame': 'Immediately after the surgery', 'description': 'Blood loss'}], 'secondaryOutcomes': [{'measure': 'Postoperative information 1', 'timeFrame': 'Postoperative in 30 days', 'description': 'Extubation time,'}, {'measure': 'Postoperative information 2', 'timeFrame': 'Postoperative in 30 days', 'description': 'Postoperative pain score: Pain score evaluation was performed after surgery ( 0-10 stands for the degree of the pain, 0 for painless and 10 for twinge).'}, {'measure': 'Postoperative information 3', 'timeFrame': 'Postoperative in 30 days', 'description': 'The usagen of analgesic drug'}, {'measure': 'Postoperative information 4', 'timeFrame': 'Postoperative in 30 days', 'description': 'Postoperative complications'}, {'measure': 'Laboratory tests information 1', 'timeFrame': '7 days before surgery and 3 days after surgery', 'description': 'The changes of hemoglobin (Hb)'}, {'measure': 'Laboratory tests information 2', 'timeFrame': '7 days before surgery and 3 days after surgery', 'description': 'the changes of creatinine (Cr)'}, {'measure': 'Laboratory tests information 3', 'timeFrame': '7 days before surgery and 3 days after surgery', 'description': 'the changes of albumin (Alb)'}, {'measure': 'Laboratory tests information 4', 'timeFrame': '7 days before surgery and 3 days after surgery', 'description': 'the changes of cardiac uhrasonography findings'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia', 'Transapical Beating-heart Septal Myectomy', 'Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': "To retrospectively analyze the preoperative, intraoperative and postoperative anesthesia management of patients with hypertrophic cardiomyopathy undergoing TA-BSM in the investigators' hospital, and to provide clinical basis for the development of reasonable and standardized perioperative anesthesia program for these patients.", 'detailedDescription': "Hypertrophic obstructive cardiomyopathy is an inherited cardiomyopathy. Such patients have significantly reduced mobility and quality of life, and are prone to sudden death in severe cases. According to conservative estimates, there are about 2 to 5 million patients with hypertrophic heart disease in China, and about 15 to 20 million patients in the world, which seriously threatens human health. The traditional surgical treatment is partial ventricular septal myectomy through thoracotomy, which is traumatic and difficult, with poor efficacy and high operative mortality in hospitals with little experience.\n\nIn order to solve this problem, professor Wei's team invented and developed a beating-heart myectomy device, and established the first transapical beating-heart septal myectomy (TA-BSM) with the aid of this device through the apical minimally invasive incision under the guidance of esophageal ultrasound. With the help of echocardiography, the position of the rotator can be monitored in real time, and the angle and thickness of the rotator can be determined to ensure the safe removal of the hypertrophic ventricular septum, so as to solve the problem of left ventricular outflow tract obstruction.\n\nThe team firstly completed 47 clinical trials from April to September 2022, with a surgical success rate of 97.9%. At 3-month follow-up, the median maximum pressure gradient of left ventricular outflow tract decreased from perioperational 86 mmHg to postoperational 19 mmHg , and 45 participants (95.7%) had complete remission of mitral regurgitation. All patients showed significant improvement or even disappearance of symptoms, and exercise capacity and quality of life were significantly improved.\n\nSince TA-BSM is a new surgical method, there is no unified standard for anesthesia management and lack of evidence-based evidence. Therefore, the aim of this study is to retrospectively analyze the preoperative, intraoperative and postoperative anesthetic management of participants with hypertrophic cardiomyopathy undergoing TA-BSM, so as to provide clinical basis for formulating reasonable and standardized perioperative anesthesia programs for these patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The information of all patients with hypertrophic cardiomyopathy undergoing TA-BSM in our hospital from April 2022 to January 2023 was extracted and screened according to the inclusion criteria and exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with hypertrophic cardiomyopathy\n* American Society of Anesthesiologists (ASA) physical status classification I-III\n* Undergoing TA-BSM\n\nExclusion Criteria:\n\n* Cardiopulmonary bypass was used to assist the surgery.'}, 'identificationModule': {'nctId': 'NCT06397092', 'briefTitle': 'Anesthetic Management for TA-BSM in HOCM', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Anesthetic Management for Transapical Beating-heart Septal Myectomy (TA-BSM) in Patients With Hypertrophic Obstructive Cardiomyopathy (HOCM)：A Retrospective Analysis', 'orgStudyIdInfo': {'id': 'TongjiHospital-Anes QQ03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TA-BSM', 'description': 'The hypertrophic cardiomyopathy patients received TA-BSM', 'interventionNames': ['Procedure: transapical beating-heart septal myectomy']}], 'interventions': [{'name': 'transapical beating-heart septal myectomy', 'type': 'PROCEDURE', 'description': 'The patients with hypertrophic cardiomyopathy undergoing TA-BSM', 'armGroupLabels': ['TA-BSM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Wenlong Yao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor and deputy chief physician', 'investigatorFullName': 'Wenlong Yao (101480)', 'investigatorAffiliation': 'Tongji Hospital'}}}}